NCT06473038

Brief Summary

This project aims to address the significant burden of cardiovascular disease in Malaysia, especially the high prevalence of hypertension with excessive salt and sugar intake. The study targets the university campus community, recognizing reliance on out-of-home food options and the potential impact of reducing salt and sugar in campus foods on overall health. The project aims to assess the knowledge, attitudes, and practices related to salt and sugar intake among students, staff, and campus canteen staff. Through a combination of surveys, dietary assessments, urine analysis, and body composition measurements, the study aims to generate valuable insights into effective strategies for reducing salt and sugar intake and improving cardiovascular health among the campus population.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
7mo left

Started Jul 2024

Typical duration for not_applicable cardiovascular-diseases

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Jul 2024Dec 2026

First Submitted

Initial submission to the registry

April 22, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

2.5 years

First QC Date

April 22, 2024

Last Update Submit

June 18, 2024

Conditions

Keywords

Salt and Sugar ReductionKnowledge, Attitude, and Practice (KAP)Hypertension

Outcome Measures

Primary Outcomes (8)

  • Part 1:Knowledge, Attitude, and Practice (KAP) on dietary salt and sugar intake among Sunway University and Sunway College community

    Firstly, understanding the community's Knowledge, Attitude, and Practice can provide baseline data on the level of awareness regarding the health implications. Addressing misconceptions and promoting healthier dietary choices. Also assessing attitudes towards reduction provides insight into the community's readiness to embrace dietary changes. The online validated questionnaire will assess: 1. Socio-demographic and lifestyle factors - questions such as age, gender, ethnicity, medical history, smoking and alcohol-drinking practices 2. Knowledge, Attitude, and Practice towards dietary salt and sugar intakes, and diabetes 3. Barriers and enablers for salt reduction Target sample size of 1000 participants is set to consider mid-study drop-outs.

    Baseline

  • Part 2: Knowledge, Attitude, and Practice (KAP) on dietary salt and sugar intake among Sunway University and Sunway College community (canteen staff)

    Food providers' understanding of the importance of salt and sugar reduction directly influences the choices they make in the kitchen. The online validated questionnaire will assess: 1. Knowledge, Attitude, and Practice towards salt and sugar usage in food preparation (including on campus) and in dietary intake 2. Perception, barriers and enablers for salt reduction during food preparation on campus The targeted number of participants is around 50 people.

    baseline

  • Part 3 Study A: Interventional study on salt and sugar reduction of selected foods sold on campus (students and staff )

    Selected samples of food sold on campus will be analysed for their sodium and sugar contents at baseline and also 3 months after the intervention of salt and sugar reduction. This will be performed using dry ashing method, followed by flame atomic absorption spectrometry (FAAS) at the Department of Nutrition, Universiti Putra Malaysia. Scale Title: Sodium Content Determination Scale Range: 0 to 100 milligrams per kilogram (mg/kg) Interpretation: Higher scores indicate higher levels of sodium content, which may be considered a worse outcome in the context of reducing sodium intake. targeted 5 food samples per vendor for 17 vendors - will yield a total number of 170 samples.

    baseline and 3 months after invention

  • Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Blood Pressure)

    Clinical measurements indicative of vascular health namely systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate will be taken using an automated blood pressure monitor (HEM- 7121, Omron, Japan) after the subjects have rested for 5 min. Measurement units: millimeters of mercury (mmHg)

    at three timepoints - at the start of the study, after 3 months and after 6 months

  • Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Wasit to Hip ratio)

    The height, waist and hip circumferences will be measured using a measuring tape and waist-hip ratio (WHR) will be calculated by dividing waist circumference by hip circumference. Measurement units: cm/inches

    at three timepoints - at the start of the study, after 3 months and after 6 months

  • Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Body Mass Index and Total body fat)

    A bio-impedance body composition scale (Omron HBF-375 Karada Scan) will be used to determine body mass index (BMI) Measurement units = kg/m2 , total body fat (TBF) = kg/m 2. The cut-off points for overweight, obesity, overall adiposity (TBF) and central adiposity (WHR) are ≥23 kg/m 2 , ≥25 kg/m 2

    at three timepoints - at the start of the study, after 3 months and after 6 months

  • Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Fats)

    A bio-impedance body composition scale (Omron HBF-375 Karada Scan) will be used to measure visceral fat (VF) measurement unit = %, subcutaneous fat (SF) measurement unit = %, skeletal muscle percentage (SM) measurement unit = % The cut-off points for overweight, obesity, overall adiposity (TBF) and central adiposity (WHR) 20% (males) or 30%

    at three timepoints - at the start of the study, after 3 months and after 6 months

  • Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Resting Metabolic Rate)

    A bio-impedance body composition scale (Omron HBF-375 Karada Scan) will measure resting metabolic rate, measurement unit = kcal/day. The cut-off points for overweight, obesity, overall adiposity (TBF), and central adiposity (WHR) 0.90 (males) or 0.85 (females)

    at three timepoints - at the start of the study, after 3 months and after 6 months

Secondary Outcomes (4)

  • Part 3 Study B: Assessment of saltiness intensity perception

    baseline and 3 months after invention

  • Part 3 Study B: Assessment of pleasantness

    baseline and 3 months after invention

  • Part 3 Study B: Urine analysis of salt and sugar reduction of selected foods sold on campus

    at three timepoints - at the start of the study, after 3 months and after 6 months

  • Part 2: Knowledge, Attitude, and Practice (KAP) on dietary salt and sugar intake among Sunway University and Sunway College community

    baseline

Study Arms (2)

Group that experience lower sodium intake

ACTIVE COMPARATOR

Lowering the salt and sugar in selected samples of foods this will be performed using dry ashing method, followed by flame atomic absorption spectrometry (FAAS) at the Department of Nutrition, Universiti Putra Malaysia.

Other: Reduction in Salt and SugarDevice: Dry Ashing Method Followed by Flame Atomic Absorption Spectrometry (FAAS)

Control group

OTHER

Participants have to provide urine samples for the measurement of urinary sodium, potassium, chloride, and creatinine, have body composition and anthropometric measurements taken, perform 24-hour dietary records, perform saltiness intensity perception and pleasantness ratings of the foods on campus, at three timepoints - at the start of the study, after 3 months and after 6 months.

Device: The potentiometer

Interventions

150 participants who are grouped under interventions, their data will be collected according to the alterations of sodium and sugar intake and then compared with the control group. Instruments include urine analysis, providing two spot urine samples - first-morning void and last void in the evening before leaving campus, at three-time points - at the start of the study, after 3 months, and after 6 months. This will yield a total of 300 × 2 × 3 = 1800 samples. Urine electrolytes (sodium, potassium, chloride) and creatinine will be measured using the potentiometry method (Alinity Abbott) at the laboratory department of Sunway Medical Centre, Bandar Sunway.

Group that experience lower sodium intake

The potentiometer is utilized for the quantitative analysis of electrolytes present in urine samples. The potentiometer used for urine electrolytes analysis is a specialized device equipped with electrodes and sensors designed to detect and measure the concentration of specific electrolytes in urine samples. It employs potentiometric principles to generate electrical signals proportional to the concentration of ions present in the sample.

Also known as: Urinal measurement device
Control group

Dry ashing method involves heating the food samples in a controlled environment to remove organic matter and moisture, leaving behind inorganic residues (ashes) containing the salts and minerals present in the food. Flame Atomic Absorption Spectrometryis utilized to measure the levels of sodium and potassium (components of salt) as well as carbon and hydrogen (components of sugar) in the ashed food samples. By determining the concentrations of these elements, the salt and sugar content of the food samples can be quantified accurately.

Group that experience lower sodium intake

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Part 1: KAP on dietary salt and sugar intake
  • Students and staff of Sunway University and Sunway College aged 18 years and above
  • Able to provide informed consent (verbal/written) to participate
  • Understands English
  • Part 2: KAP, Perception, Barriers and Enablers of Salt and Sugar Reduction among Campus Canteen Staff
  • Canteen staff that are involved in food preparation aged 18 years and above
  • Able to provide informed consent (verbal/written) to participate
  • Understands English
  • Part 3: An interventional study for 6 months will expose them to foods sold on campus that have reduced salt and sugar.
  • For intervention group
  • Individuals who eat on campus food for at least 3 meals per week
  • Consent to participate
  • For control group
  • Individuals who do not eat on campus food or for less than 3 meals per week
  • Consent to participate

You may not qualify if:

  • \. Individuals with acute illness, psychological or psychiatric conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chia YC, Say YH, Cheng MH, Chung FFL, Lau TP, Ooi PB. Reduction of Salt and Sugar Contents in Canteen Foods and Intakes By Students and Staff at a Malaysian Higher Education Institution: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2025 Jul 21;14:e69610. doi: 10.2196/69610.

MeSH Terms

Conditions

Cardiovascular DiseasesBehaviorHypertension

Interventions

SaltsSugars

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

Inorganic ChemicalsCarbohydrates

Study Officials

  • Yook Chia Chin, MD

    Sunway University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yook Chin Chia, MD

CONTACT

Pei Boon P Ooi, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants who eat often foods sold on campus will be selected from the online validated questionnaire (part 1) in a randomized manner and they form the intervention group who will be eating the foods sold on campus that have reduced salt and sugar. Participants who do not eat often the food sold on campus will be the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department, School of Medical & Life Sciences

Study Record Dates

First Submitted

April 22, 2024

First Posted

June 25, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

The data collected from the study will be encrypted via a password-protected file and can only be accessed by the researchers of this study. The password-protected file will be kept at Sunway University for up to five years (only if this research is successfully published in a scientific journal, presented at a conference, or published through other media).